Device Classification Name |
nasopharyngoscope (flexible or rigid)
|
510(k) Number |
K031648 |
Device Name |
VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V |
Applicant |
OLYMPUS OPTICAL CO., LTD. |
TWO CORPORATE CENTER DR. |
MELVILLE,
NY
11747 -3157
|
|
Applicant Contact |
TINA STEFFANIE-OAK |
Correspondent |
OLYMPUS OPTICAL CO., LTD. |
TWO CORPORATE CENTER DR. |
MELVILLE,
NY
11747 -3157
|
|
Correspondent Contact |
TINA STEFFANIE-OAK |
Regulation Number | 874.4760
|
Classification Product Code |
|
Date Received | 05/28/2003 |
Decision Date | 07/24/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|